NCT02139878

Brief Summary

Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 17, 2017

Completed
Last Updated

March 28, 2017

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

May 4, 2014

Results QC Date

October 24, 2016

Last Update Submit

February 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Systolic blood pressure

    Up to 4 weeks

Secondary Outcomes (1)

  • Glucose

    Up to 4 weeks

Study Arms (2)

Wild blueberry juice

EXPERIMENTAL

240 ml wild blueberry juice

Other: Wild blueberry juice

Placebo wild blueberry juice

PLACEBO COMPARATOR

240 ml placebo wild blueberry juice

Other: Placebo wild blueberry juice

Interventions

Wild blueberry juice
Placebo wild blueberry juice

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals at risk for type 2 diabetes

You may not qualify if:

  • have a body mass index of less than 20 and greater than 45 kg/m2.
  • are less than 21 and greater than 65 years old at beginning of study
  • have smoked or used tobacco within 6 months prior to the start of the study
  • are pregnant, plan to become pregnant or become pregnant during the study
  • have a history or presence of kidney disease, liver disease, certain cancers, gastrointestinal, other metabolic diseases, or malabsorption syndromes
  • have type 2 diabetes and need to use oral diabetic drugs or insulin
  • have an allergy or adverse reaction to blueberries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Prince Edward Island, Health Sciences

Charlottetown, Prince Edward Island, C1A 4P3, Canada

Location

Related Publications (1)

  • Stote KS, Sweeney MI, Kean T, Baer DJ, Novotny JA, Shakerley NL, Chandrasekaran A, Carrico PM, Melendez JA, Gottschall-Pass KT. The effects of 100% wild blueberry (Vaccinium angustifolium) juice consumption on cardiometablic biomarkers: a randomized, placebo-controlled, crossover trial in adults with increased risk for type 2 diabetes. BMC Nutr. 2017 May 25;3:45. doi: 10.1186/s40795-017-0164-0. eCollection 2017.

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Kim S. Stote PhD, MPH, RD
Organization
University of Prince Edward Island

Study Officials

  • Katherine Gottschall-Pass, PhD, RD

    University of Prince Edward Island

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Chair of Nutrisciences and Health

Study Record Dates

First Submitted

May 4, 2014

First Posted

May 15, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 28, 2017

Results First Posted

February 17, 2017

Record last verified: 2016-12

Locations